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A Randomized, Open-label, Study of CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Patients With Melanoma

This study is evaluating CMP-001 in combination with nivolumab in subjects with unresectable or metastatic melanoma.

Trial ID: NCT04695977

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Trial Details

We want to evaluate the safety and efficacy of the study drug, CMP-001, used in combination with an already approved drug, nivolumab, and determine if it can improve cancer treatment compared to nivolumab on its own. Metastatic or unresectable melanoma is melanoma that has either spread to other parts of the body or is unable to be removed by surgery. The goals of treatment are to shrink or stop the growth of the disease where it has spread and stop it from spreading to new areas. Nivolumab is already approved to treat this type of cancer and will be provided intravenously. CMP-001 provides treatment directly into the tumor through an alternative mechanism than nivolumab, and the goal is to further increase the efficacy of treating the cancer through this dual approach. This study is divided into two phases: Phase 2 and Phase 3. The Phase 2 part of the study is designed to look at the safety and objective response rate (ORR) following treatment. The Phase 3 part of the study is designed to look at additional safety measures along with the progression-free survival (PFS), overall survival (OS), and additional efficacy measures. To determine if you can take part in the study, you will need to visit a study center to undergo medical tests and assessments. The eligibility visit and screening period will be up to 1 month before the start of the study.

Estimated Enrollment

450

Phase

2/3

Commitment to Diversity & Inclusion

Checkmate is committed to ensuring the safety of all study participants and has taken steps to recruit patients from different backgrounds and populations.

We will use this research study to collect information to determine if the investigational drug could one day be made available to the public.

Eligibility Criteria

Participants must:

Main criteria below. Note: Any additional criteria will be confirmed at the study clinic

  • Be male or female and at least 18 years of age.
  • Have unresectable or metastatic, stage 3 or stage 4 melanoma.
  • Have at least one tumor that meets the criteria for direct injection of drug treatment, and one or more other tumors that will be evaluated during treatment.
  • Be willing to provide a tumor biopsy, previous or newly obtained.
  • Have adequate organ function.
  • Be willing to use contraception.
  • Be able to provide written informed consent.

Participants must not have:

Main criteria below. Note: Any additional criteria will be confirmed at the study clinic

  • Uveal, acral, or mucosal melanoma.
  • Received prior systemic treatment for melanoma in the unresectable or metastatic setting (except adjuvant therapy)
  • Received prior therapy with CMP-001.
  • Steroid treatment greater than 10 mg/day.
  • Be pregnant or breastfeeding.
  • A life expectancy of less than 3 months.
  • Known additional malignancy that has progressed or required active treatment within the past 3 years (exceptions allowed).
  • History of adverse events to certain treatments.
  • Any concurrent uncontrolled illness, including mental illness or substance abuse, or an active/suspected illness or infection.
  • Participated in another clinical study of an investigational anticancer treatment within 30 days.

What Will Happen in This Study

Following the screening assessment, the participant will be placed in 1 of 2 groups. One group will receive CMP-001 and nivolumab, and the other will receive nivolumab alone. CMP-001 is given intratumorally (into the tumor) once a week for 7 weeks, followed by treatment once every 3 weeks. Nivolumab will be given intravenously once every 3 weeks. Evaluations will occur during and after treatment, at least through 30 weeks and up to 2 years.

Where to Join

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Location
Status
California Cancer Associates for Research & Excellence, Inc., San Marcos, CA, 92069, United States
Recruiting
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, 19107, United States
Recruiting
Hartford Healthcare, Hartford, Connecticut, 06103, United States
Inactive
University Cancer & Blood Center, LLC, Athens, GA, 30607, United States
Inactive
Texas Oncology - Sammons Cancer Center, Dallas, TX, 75246, United States
Inactive
Ohio State University Wexner Medical Center, Columbus, OH, 43210, United States
Inactive
Seattle Cancer Care Alliance, Seattle, Washington, 98109, United States
Recruiting

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